Prophylaxis of graft rejection following heart
transplantation without antibody induction, starting
within 12 hours of transplantation
▶BY MOUTH
▶Neonate:Initially 150 micrograms/kg twice daily, dose to
be given as soon as clinically possible ( 8 – 12 hours after
discontinuation of intravenous infusion).▶Child:Initially 150 micrograms/kg twice daily, dose to
be given as soon as clinically possible ( 8 – 12 hours after
discontinuation of intravenous infusion)
Allograft rejection resistant to conventional
immunosuppressive therapy
▶BY MOUTH
▶Child:Seek specialist advice
VIVADEX®
Prophylaxis of graft rejection following liver
transplantation, starting 12 hours after transplantation
▶BY MOUTH
▶Neonate:Initially 150 micrograms/kg twice daily.▶Child:Initially 150 micrograms/kg twice daily
Prophylaxis of graft rejection following kidney
transplantation, starting within 24 hours of
transplantation
▶BY MOUTH
▶Neonate:Initially 150 micrograms/kg twice daily.▶Child:Initially 150 micrograms/kg twice daily, a lower
initial dose of 100 micrograms/kg twice daily has been
used in adolescents to prevent very high‘trough’
concentrations
Prophylaxis of graft rejection following heart
transplantation following antibody induction, starting
within 5 days of transplantation
▶BY MOUTH
▶Neonate:Initially 50 – 150 micrograms/kg twice daily.▶Child:Initially 50 – 150 micrograms/kg twice daily
Prophylaxis of graft rejection following heart
transplantation without antibody induction, starting
within 12 hours of transplantation
▶BY MOUTH
▶Neonate:Initially 150 micrograms/kg twice daily, dose to
be given as soon as clinically possible ( 8 – 12 hours after
discontinuation of intravenous infusion).▶Child:Initially 150 micrograms/kg twice daily, dose to
be given as soon as clinically possible ( 8 – 12 hours after
discontinuation of intravenous infusion)
Allograft rejection resistant to conventional
immunosuppressive therapy
▶BY MOUTH
▶Child:Seek specialist advicelUNLICENSED USE
ADVAGRAF®Advagraf®not licensed for use in children.IMPORTANT SAFETY INFORMATION
MHRA/CHM ADVICE: ORAL TACROLIMUS PRODUCTS: PRESCRIBE
AND DISPENSE BY BRAND NAME ONLY, TO MINIMISE THE RISK OF
INADVERTENT SWITCHING BETWEEN PRODUCTS, WHICH HAS BEEN
ASSOCIATED WITH REPORTS OF TOXICITY AND GRAFT REJECTION
(JUNE 2012)
Inadvertent switching between oral tacrolimus products
has been associated with reports of toxicity and graft
rejection. To ensure maintenance of therapeutic
response when a patient is stabilised on a particular
brand, oral tacrolimus products should be prescribed and
dispensed by brand name only..Adoport®,Prograf®,Capexion®,Tacni®, andVivadex®
are immediate-release capsules that are taken twice
daily, once in the morning and once in the evening;
.Modigraf®granules are used to prepare an immediate-
release oral suspension which is taken twice daily,
once in the morning and once in the evening;
.Advagraf®is a prolonged-release capsule that is taken
once daily in the morning.
Switching between tacrolimus brands requires careful
supervision and therapeutic monitoring by an
appropriate specialist.
Important:Envarsus®is not interchangeable with
other oral tacrolimus containing products; the MHRA
has advised (June 2012 ) that oral tacrolimus products
should be prescribed and dispensed by brand only.lCAUTIONSIncreased risk of infections.
lymphoproliferative disorders.malignancies.
neurotoxicity.QT-interval prolongation.UV light (avoid
excessive exposure to sunlight and sunlamps)
lINTERACTIONS→Appendix 1 : tacrolimus
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonAlopecia.anaemia.anxiety.
appetite decreased.arrhythmias.ascites.asthenic
conditions.bile duct disorders.confusion.consciousness
impaired.constipation.coronary artery disease.cough.
depression.diabetes mellitus.diarrhoea.dizziness.
dysgraphia.dyslipidaemia.dyspnoea.electrolyte
imbalance.embolism and thrombosis.eye disorder.
febrile disorders.fluid imbalance.gastrointestinal
discomfort.gastrointestinal disorders.gastrointestinal
inflammatory disorders.haemorrhage.hallucination.
headache.hearing impairment.hepatic disorders.
hyperglycaemia.hyperhidrosis.hypertension.
hyperuricaemia.hypotension.increased risk of infection.
ischaemia.joint disorders.leucocytosis.leucopenia.
metabolic acidosis.mood altered.muscle spasms.nasal
complaints.nausea.nephropathy.nervous system
disorder.oedema.oral disorders.pain.peripheral
neuropathy.peripheral vascular disease.primary
transplant dysfunction.psychiatric disorder.renal
impairment.renal tubular necrosis.respiratory disorders.
seizure.sensation abnormal.skin reactions.sleep
disorders.temperature sensation altered.
thrombocytopenia.tremor.urinary tract disorder.urine
abnormal.vision disorders.vomiting.weight changes
▶UncommonAsthma.cardiac arrest.cardiomyopathy.
cataract.central nervous system haemorrhage.chest
discomfort.coagulation disorders.coma.dysmenorrhoea
.encephalopathy.feeling abnormal.haemolytic anaemia.
heart failure.hypoglycaemia.hypoproteinaemia.
influenza like illness.memory loss.multi organ failure.
neutropenia.palpitations.pancreatitis.pancytopenia.
paralysis.paresis.photosensitivity reaction.psychotic
disorder.shock.speech disorder.stroke.ventricular
hypertrophy
▶Rare or very rareFall.hirsutism.mobility decreased.
muscle tone increased.muscle weakness.pancreatic
pseudocyst.pericardial effusion.QT interval prolongation
.severe cutaneous adverse reactions (SCARs).sinusoidal
obstruction syndrome.thirst.ulcer
▶Frequency not knownAgranulocytosis.malignancy.
neoplasms.polyomavirus-associated nephropathy.
progressive multifocal leukoencephalopathy.pure red cell
aplasia
SPECIFIC SIDE-EFFECTS
▶With intravenous useAnaphylactoid reaction (due to
excipient).hypersensitivity
SIDE-EFFECTS, FURTHER INFORMATIONCardiomyopathy
has been reported to occur primarily in children with524 Immune system disorders and transplantation BNFC 2018 – 2019
Immune system and malignant disease8